Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description
As a QBMS automation validation engineer for PM3, you will be responsible for ensuring that the Automation Building Management System to support the HVAC in the PM3 and warehouse facility are in compliance with Division Quality System requirements and recognised international standards. In this role you will support the existing Automation Team with generation and review of documentation and execution activities and support the team as required.
Major Responsibilities
• Implementation of Validation Plans, qualification of the automation systems, support for Functional testing and Process Qualifications (PQs)
• Working with the team to ensure all aspects of activity within the Validation group adhere to required policies and procedures, including safety and training.
• Ensure that the Project meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
• Be involved in all Project Workstreams to ensure adherence to required policies and procedures.
• Generate, Execute, Pre-approve and post-approve user requirement specifications, functional specifications, validation protocols and assessments from a quality system documentation perspective.
• Collate and report on relevant Validation data.
• Ensure prompt attention and remediation for deviations and non conformances
with diverse personalities.
Requirements:
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Minimum 8-10 years experience in a similar role.
• Experience in the development and support of a Validation system an advantage.
• A third level qualification in Science, Engineering or a relevant Quality discipline.
Package:
Minimum 6 month contract
Rate €45 per hour
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
QBMS Automation Validation Engineer for PM3 - Amgen -Dublin
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description
As a QBMS automation validation engineer for PM3, you will be responsible for ensuring that the Automation Building Management System to support the HVAC in the PM3 and warehouse facility are in compliance with Division Quality System requirements and recognised international standards. In this role you will support the existing Automation Team with generation and review of documentation and execution activities and support the team as required.
Major Responsibilities
• Implementation of Validation Plans, qualification of the automation systems, support for Functional testing and Process Qualifications (PQs)
• Working with the team to ensure all aspects of activity within the Validation group adhere to required policies and procedures, including safety and training.
• Ensure that the Project meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards
• Be involved in all Project Workstreams to ensure adherence to required policies and procedures.
• Generate, Execute, Pre-approve and post-approve user requirement specifications, functional specifications, validation protocols and assessments from a quality system documentation perspective.
• Collate and report on relevant Validation data.
• Ensure prompt attention and remediation for deviations and non conformances
with diverse personalities.
Requirements:
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Minimum 8-10 years experience in a similar role.
• Experience in the development and support of a Validation system an advantage.
• A third level qualification in Science, Engineering or a relevant Quality discipline.
Package:
Minimum 6 month contract
Rate €45 per hour
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
